drugset / Trial / NCT03757234

IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

NCT03757234

Phase 2 Completed 201 enrolled Paratek Pharmaceuticals Inc
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of female adults with acute pyelonephritis.

Timeline

Start
2018-11-19
Primary completion
2019-06-26
Completion
2019-07-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levofloxacin Small molecule 750 mg Intravenous
Subject Omadacycline Small molecule 100 mg Intravenous
Subject Omadacycline Small molecule 200 mg Intravenous
Subject Omadacycline Small molecule 300 mg Intravenous
Subject Omadacycline Small molecule 450 mg Intravenous

Indications